Belantamab mafodotin

LONDON, UK I November 14, 2024 I GSK plc (LSE/NYSE: GSK) today announced positive headline results from a planned interim analysis of the DREAMM-7 head-to-head phase III trial evaluating Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex) as a second-line or later treatment for relapsed or refractory multiple myeloma. The trial met the key secondary endpoint of overall survival (OS), showing that belantamab mafodotin when combined with BorDex significantly reduced the risk of death versus standard of care daratumumab plus BorDex. Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said : “The overall survival results from the DREAMM-7 trial underscore the potential for this Blenrep combination to extend the lives of patients with relapsed/refractory multiple myeloma. This is a statistically significant and clinically meaningful advancement for patients and potentially transformative for treatment. We look forward to sharing these data with health authorities and presenting the full results at next month’s American Society of Hematology Annual Meeting.” Results from the interim analysis, including safety data, will be presented at the upcoming 66th American Society of Hematology (ASH) Annual Meeting and Exposition on 9 December 2024 at 11:15 a.m. PT. The DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical development programme continues to evaluate the potential of belantamab mafodotin in early lines of treatment and in combination with novel therapies and standard of care treatments. In addition to DREAMM-7, this includes the ongoing head-to-head phase III DREAMM-8 trial evaluating belantamab mafodotin in combination with pomalidomide and dexamethasone versus bortezomib in combination with pomalidomide and dexamethasone. A phase III study in newly diagnosed transplant ineligible multiple myeloma is expected to be initiated by the end of 2024 as part of the DREAMM programme. In 2024, belantamab mafodotin combinations have been filed in the US, European Union 1 , Japan 2 , United Kingdom, Canada and Switzerland for the treatment of relapsed or refractory multiple myeloma based on the results of the DREAMM-7 and DREAMM-8 trials. In China 3 , the National Medical Products Administration has granted Breakthrough Therapy Designation for belantamab mafodotin in combination with BorDex, as well as priority review for the regulatory application based on the results of DREAMM-7. About DREAMM-7 The DREAMM-7 phase III clinical trial is a multicentre, open-label, randomised trial evaluating the efficacy and safety of belantamab mafodotin in combination with BorDex compared to a combination of daratumumab and BorDex in patients with relapsed/refractory multiple myeloma who previously were treated with at least one prior line of multiple myeloma therapy, with documented disease progression during or after their most recent therapy. A total of 494 participants were randomised at a 1:1 ratio to receive either belantamab mafodotin in combination with BorDex or a combination of daratumumab and BorDex. Belantamab mafodotin was scheduled to be dosed at 2.5mg/kg intravenously every three weeks. The primary endpoint is PFS as per an independent review committee. The key secondary endpoints include OS, duration of response (DOR), and minimal residual disease (MRD) negativity rate as assessed by next-generation sequencing. Other secondary endpoints include overall response rate (ORR), safety, and patient reported and quality of life outcomes. Results from DREAMM-7 were first presented 4 at the American Society of Clinical Oncology (ASCO) Plenary Series in February 2024, shared in an encore presentation at the 2024 ASCO Annual Meeting, and published in the New England Journal of Medicine. About multiple myeloma Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable. 5,6 There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year. 7 Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments. 8 About Blenrep Blenrep is an antibody-drug conjugate comprising a humanised B-cell maturation antigen monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seagen Inc.; the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc., a member of the Kyowa Kirin Group. Blenrep is approved as monotherapy in Hong Kong, Israel and Singapore. Refer to the local Summary of Product Characteristics for a full list of adverse events and complete important safety information. GSK in oncology Oncology is an emerging therapeutic area for GSK where we are committed to maximising patient survival with a current focus on haematologic malignancies, gynaecologic cancers, and other solid tumours through breakthroughs in immuno-oncology and tumour-cell targeting therapies. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. References SOURCE: GlaxoSmithKline

11月14日，GSK宣布一项评估BCMA ADC药物Blenrep（belantamab mafodotin）联合硼替佐米和地塞米松（BorDex）头对头对比达雷妥尤单抗联合BorDex二线治疗复发或难治性多发性骨髓瘤（RRMM）的III期DREAMM-7研究的中期分析取得积极结果，到达了总生存期（OS）的关键次要终点。详细数据将在12月举行的第66届美国血液学会 （ASH） 年会上公布。 DREAMM-7 研究是一项多中心、开放标签随机试验，共纳入494例患者，按1:1比例随机分组接受belantamab mafodotin与BorDex联合治疗，或接受达雷妥尤单抗与BorDex联合治疗。Belantamab mafodotin试验组每3周静脉注射一次，每次剂量为2.5mg/kg。研究主要终点指标为中位无进展生存期（PFS），次要终点包括OS、缓解持续时间（DOR）、微小残留病（MRD）阴性率等。 此前已公布的临床试验数据显示，belantamab mafodotin治疗组患者（n=243）的PFS为36.6个月（95% CI：28.4-NR），较对照组患者（n=251）的13.4个月（95% CI：11.1-17.5）延长了近2年，并且疾病进展或死亡风险降低了近60%（HR：0.41，95% CI：0.31-0.53，p<0.00001），达到了主要终点。 DREAMM项目将继续评估belantamab mafodotin治疗早期患者以及与创新疗法和标准治疗方案联合应用的潜力。除DREAMM-7研究外，该项目还包括一系列临床研究。其中正在进行的头对头III期DREAMM-8研究，评估belantamab mafodotin联合泊马度胺和地塞米松（BPd）与泊马度胺联合硼替佐米和地塞米松（PVd）治疗RRMM的效果。 作为DREAMM项目的一部分，GSK还将于2024年底启动一项针对新确诊的不符合干细胞移植手术指征的多发性骨髓瘤患者的III期临床研究。 Copyright © 2024 PHARMCUBE. All Rights Reserved. 欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。 免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。